The occurrence of foodborne illnesses or other food safety
incidents could also adversely affect the price and availability of
affected raw materials, resulting in higher costs, disruptions in
supply and a reduction in sales. Furthermore, any instances of food
contamination or regulatory noncompliance, whether or not caused by
our actions, could compel us, our suppliers, distributors or
customers, depending on the circumstances, to conduct a recall in
accordance with FDA regulations, and comparable state laws. Food
recalls could result in significant losses due to their costs, the
destruction of product inventory, lost sales due to the
unavailability of the product for a period of time and potential
loss of existing distributors or customers and a potential negative
impact on our ability to attract new customers due to negative
consumer experiences or because of an adverse impact on our brand
and reputation. The costs of a recall could be outside the scope of
our existing or future insurance policy coverage or limits.
In addition, food companies have been subject to targeted,
large-scale tampering as well as to opportunistic, individual
product tampering, and we, like any food company, could be a target
for product tampering. Forms of tampering could include the
introduction of foreign material, chemical contaminants, and
pathological organisms into consumer products as well as product
substitution. FDA regulations require companies like us to analyze,
prepare, and implement mitigation strategies specifically to
address tampering designed to inflict widespread public health
harm. If we do not adequately address the possibility, or any
actual instance, of product tampering, we could face possible
seizure or recall of our products, suspension of our facilities’
registrations, and/or the imposition of civil or criminal
sanctions, which could materially adversely affect our business,
financial condition, and operating results.
Our operations
are subject to FDA and USDA governmental regulation and state
regulation, and there is no assurance that we will be in compliance
with all regulations.
Our operations are subject to extensive regulation by the FDA and
other federal, state and local authorities. Specifically, we are
subject to the requirements of the Federal Food, Drug and Cosmetic
Act and regulations promulgated thereunder by the FDA. This
comprehensive regulatory program governs, among other things, the
manufacturing, composition and ingredients, packaging, labeling and
safety of food. Under this program, the FDA requires that
facilities that grow, pack, and/or process food products comply
with a range of requirements, including standards for the growing,
harvesting, packing, and holding of produce, hazard analysis and
preventative controls regulations, current good manufacturing
practices, and supplier verification requirements. Our processing
facilities are subject to periodic inspection by federal, state and
local authorities. If we cannot successfully manufacture products
that conform to our specifications and the strict regulatory
requirements of the FDA or others, we may be subject to adverse
inspectional findings or enforcement actions, which could
materially impact our ability to market our products, or could
result in a recall of our product that have already been
distributed. If the FDA or a comparable foreign regulatory
authority determines that we have not complied with the applicable
regulatory requirements, our business may be materially
impacted.
We seek to comply with applicable regulations through a combination
of employing internal experience and expert personnel to ensure
quality-assurance compliance (i.e., assuring that products are not
adulterated or misbranded) and contracting with third-party
laboratories that conduct analyses of products to ensure compliance
with nutrition labeling requirements and to identify any potential
contaminants before distribution. Failure by us to comply with
applicable laws and regulations or maintain permits, licenses or
registrations relating to our operations could subject us to civil
remedies or penalties, including fines, injunctions, recalls or
seizures, warning letters, restrictions on the marketing or
manufacturing of products, or refusals to permit the import or
export of products, as well as potential criminal sanctions, which
could result in increased operating costs resulting in a material
effect on our operating results and business.
Changes in
existing laws or regulations, or the adoption of new laws or
regulations, may increase our costs and otherwise adversely affect
our business, results of operations and financial
condition.
The manufacture and marketing of food products is highly regulated.
We and our suppliers are subject to a variety of laws and
regulations. These laws and regulations apply to many aspects of
our business, including the manufacture, packaging, labeling,
distribution, advertising, sale, quality, and safety of our
products, as well as the health and safety of our employees and the
protection of the environment.
In the United States, we are subject to regulation by various
government agencies, including the FDA, Federal Trade Commission
(the “FTC”), Occupational Safety and Health Administration
(“OSHA”), Environmental Protection Agency (the “EPA”), and USDA, as
well as various state and local agencies. We are also regulated
outside the United States by various international regulatory
bodies. In addition, depending on customer specification, we may be
subject to certain voluntary, third-party standards, such as Global
Food Safety Initiative standards and review by voluntary
organizations, such as the Council of Better Business Bureaus’
National Advertising Division. We could incur costs, including
fines, penalties and third-party claims, because of any violations
of, or liabilities under, such requirements, including any
competitor or consumer challenges relating to compliance with such
requirements. The loss